Abstract
Background: Open-label, single-centre Phase II trial evaluating the toxicity and antitumour activity of weekly docetaxel in the second-line management of advanced non-small cell lung cancer (NSCLC). Patients and Methods: Treatment comprised docetaxel 35 mg/m2 weekly for 6 weeks followed by 2 weeks' rest for a maximum of 3 cycles. Results: Thirty-six patients received 220 weekly doses of docetaxel. Toxicity was generally mild: no grade 3-4 haematological toxicity; one grade 4 non-haematological event (bloody diarrhoea in a patient with pre-existing colon diverticulitis). Nausea (11%) and asthenia (8%) constituted the main grade 3 non-haematological toxicities. The objective response rate was 11% (14% minor response, 25% stable disease) and the median duration of survival upon the initiation of docetaxel was 160 days, with a 1-year survival rate of 23%. Conclusion: Docetaxel is active and well tolerated in the second-line treatment of advanced NSCLC and appears to yield an improved therapeutic index versus 3-weekly regimens.
Footnotes
- Received July 10, 2003.
- Accepted November 25, 2003.
- Copyright© 2004 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved
